250 IU, 1250 IU Powder, and solvent for solution for injection/infusion 
Human coagulation factor XIII

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Cluvot is and what it is used for 
2. What you need to know before you use Cluvot 
3. How to use Cluvot 
4. Possible side effects 
5. How to store Cluvot 
6. Contents of the packaging and other information 

1. What Cluvot is and what it is used for

What is Cluvot?

Cluvot consists of a white powder and a diluent which is prepared into a finished solution. The solution is given as an injection into a vein.

Cluvot contains coagulation factor XIII (FXIII) from human plasma (the fluid part of the blood) and has an important hemostatic function (stops bleeding).

What is Cluvot used for?

Cluvot is used in adults and children

  • as a preventive treatment for congenital factor XIII deficiency and
  • for the treatment of bleeding during surgery of patients with congenital FXIII deficiency.

Human coagulation factor XIII contained in Cluvot may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Cluvot

The following sections provide information that your doctor should consider before taking Cluvot.

Do not use Cluvot:

  • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Tell your doctor if you have any drug or food allergies.

Warnings and cautions

Talk to your doctor before using Cluvot:

  • if you have previously had allergic reactions to FXIII. You should take antihistamines and corticosteroids for prevention if your doctor advises you to do so.
  • if an allergic or anaphylactic reaction occurs (a severe allergic reaction that causes great difficulty breathing or dizziness). The use of Cluvot should then be stopped immediately (injection/infusion stopped). In case of medical shock, standard medical treatment should be used.
  • if you have a history of thrombosis (blood clot). Caution should be exercised due to the ability of FXIII to affect blood coagulation (fibrin stabilizing effect).

A known complication of the treatment is the formation of inhibitors (neutralizing antibodies ), which means that the treatment stops working. If your bleeding can not be controlled with Cluvot, consult your doctor immediately. You should then be closely monitored for the formation of antibodies.

Your doctor will carefully consider the benefits of Cluvot treatment compared to the risk of the above complications.

Virus security

When medicines are made from human blood or plasma, special measures are taken to prevent the transmission of infection to patients. This includes:

  • a careful selection of blood and plasma donors to ensure that people at risk of being carriers are excluded.
  • testing of individual donations and plasma pools for signs of viruses/infections.
  • steps to inactivate or remove viruses during production from blood and plasma.

Nevertheless, the risk of transmission of infection can not be completely ruled out when drugs made from human blood or plasma are given. This also applies to unknown or new viruses or other types of infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus ( HIV ), hepatitis B, and hepatitis C virus, and against non-enveloped viruses a hepatitis A and parvovirus B19.

It is strongly recommended that your doctor record the product name and batch number of the medicine (indicated on the carton) each time you receive Cluvot.

Your doctor may suggest vaccination against hepatitis A and B if you are regularly / repeatedly treated with drugs made from human plasma.

Other medicines and Cluvot

  • Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
  • There are no known interactions between concentrates containing human coagulation factor XIII and other drugs.
  • Cluvot should not be mixed with other medicinal products, solutions, or diluents other than those listed in section 6 and these should be administered with a separate infusion line.

Pregnancy, breastfeeding, and fertility

  • If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
  • Limited data from the use of Cluvot in pregnant women do not indicate any adverse effects during pregnancy or on the health of the fetus / newborn baby. Therefore, Cluvot can be used during pregnancy when deemed necessary.
  • There are no data on the excretion of Cluvot in breast milk. Because FXIII is a large molecule, excretion in breast milk is unlikely and due to its protein properties, absorption of intact molecules in the baby is also unlikely. Cluvot can therefore be used during breast-feeding.
  • There are no data available on fertility.

Driving and using machines

No studies on the ability to drive and use machines have been performed.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Cluvot contains sodium

Be aware that Cluvot contains sodium. This should be considered if you have been prescribed a low-salt diet. Cluvot contains 124.4-195.4 mg (5.41‑8.50 mmol) of sodium per dose (40 IU / kg body weight – for normal weight of 70 kg) if the recommended dose is one (2800 IU = 44.8 ml) ges.

3. How to use Cluvot

  • Cluvot is usually given by a doctor.
  • Cluvot is only to be given as an injection into a vein.

Dosage

Your doctor will calculate the dose you need and how often Cluvot should be given to you, taking into account how well the treatment is working.

For more information, see the section “The following information is intended for healthcare professionals only”.

If you use more Cluvot then you should 

No cases of overdose have been reported and this is not expected as healthcare professionals are giving the medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed in rare cases (affects more than 1 user in 10,000 and less than 1 in 1,000 users):

  • Allergic reactions such as urticaria (itchy swelling of the skin), rash, drop in blood pressure (which may make you feel dizzy or faint), and difficulty breathing.
  • Elevated body temperature

The following side effects have been observed in very rare cases (affects less than 1 user in 10,000):

  • The formation of the antibody is against FXIII.

If allergic reactions occur, administration of Cluvot must be stopped immediately and appropriate treatment initiated. In the event of a medical shock, the applicable standard medical treatment must be applied.

Side effects are in children and adolescents

Side effects in children and adolescents are expected to be the same as in adults.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

5. How to store Cluvot

  • Store in a refrigerator (2 ° C – 8 ° C).
  • Do not freeze.
  • Keep the vial in the outer carton. Sensitive to light.
  • Cluvot does not contain any preservatives. The reconstituted solution should be given immediately. If the solution is not used immediately, the storage time should not exceed 4 hours at room temperature. The reconstituted solution should not be stored refrigerated or frozen.
  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the label and carton.

6. Contents of the packaging and other information

Content declaration

The active substance is:

Human coagulation factor XIII, 250 IU, and 1250 IU, respectively, per vial.

IU = IE (International Units)

Other ingredients are:

Human albumin, glucose monohydrate, sodium chloride, sodium hydroxide (in small amounts for pH adjustment ).

Diluent: Water for injections.

What the medicine looks like and the contents of the pack

Cluvot is supplied as a white powder together with a diluent (water for injections). The reconstituted solution should be colorless, clear to slightly opalescent. When held against the light, it should not be cloudy or contain precipitates/particles.

Packaging:

One pack of 250 IU contains

  • 1 vial of powder
  • 1 vial with 4 ml of water for injections
  • 1 transfer set with filter 20/20 (Mix2Vial)

Accessories for administration (inner carton):

  • 1 disposable syringe (5 ml)
  • 1 venipuncture set
  • 2 alcohol dryers
  • 1 non-sterile patch

One pack of 1250 IU contains

  • 1 vial of powder
  • 1 vial with 20 ml water for injections
  • 1 transfer set with filter 20/20 (Mix2Vial)

Accessories for administration (inner carton):

  • 1 disposable syringe (20 ml)
  • 1 venipuncture set
  • 2 alcohol dryers
  • 1 non-sterile patch

Marketing Authorization Holder and Manufacturer

CSL Behring GmbH

Emil-von-Behring-Strasse 76

35041 Marburg

Germany

Further information on this medicine can be obtained from the representative of the marketing authorization holder:

CSL Behring AB

Box 712

182 17 Dande

Muhammad Nadeem

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